MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS BRAIDED PERIPHERAL CATHETER; DIAGNOSTIC PERIPHERIAL CATHETER

Catalog Number 412538BER

Device Problems Fracture (1260); Material Separation (1562)

Patient Problems Death (1802); Non specific EKG/ECG Changes (1817); Blood Loss (2597); Foreign Body In Patient (2687)

Event Date 04/02/2020

Event Type  Death  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The physician alleges that during an interventional peripheral vascular chronic total occlusion [cto] procedure, the catheter tip detached within the (b)(6)-year-old male patient.Post-procedure, the patient expired.The physician had acquired right antegrade radial artery access, and bilateral retrograde femoral artery access in attempts to treat a cto of the of the native common iliac artery.The physician had acquired glide-wire access via right radial and bilateral femoral arteries and had negotiated the patient's common iliac bifurcation with an.035 j guidewire and a 4f, 125cm catheter.During catheter manipulations over the glide wire, within the patient's heavily calcified and diseased common iliac artery, the catheter tip [10cm] detached.The physician was unsuccessful in removing the foreign body with a vascular snare device.During attempts to re-position the foreign body for a better angle of capture within the patient, the patient's ecg demonstrated ventricular tachycardia [v-tac] then ventricular fibrillation [v-fib].The clinical staff executed a code blue and advanced cardiac life support [acls] protocols were successfully executed.During a continued effort to again manipulate, acquire and remove the patient's foreign body, the physician perforated the wall of the patient's common iliac artery.The procedure again was considered emergent due to the severe internal blood loss.A blood transfusion was necessary to stabilize the patient and again, all lifesaving attempts made by the clinical staff were successful.A covered stent was emergently deployed within the patient's common iliac artery (jailing) the detached catheter tip within and against the tunica intima [inner luminal wall] of the artery.Post-procedure, the patient was transferred to and intensive care unit [icu] for continual observation and expired later that evening.

Manufacturer Narrative

The suspect device has been returned for evaluation.The complaint is confirmed.No definitive root cause could be determined however, it is likely that significant force was applied to the device during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: IMPRESS BRAIDED PERIPHERAL CATHETER
• Type of Device: DIAGNOSTIC PERIPHERIAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 9945999
• MDR Text Key: 187125249
• Report Number: 3010665433-2020-00010
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00088445003808
• UDI-Public: 0088445003808
• Combination Product (y/n): N
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 412538BER
• Device Lot Number: E1589817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COVERED STENT; TERUMO .035 GLIDE WIRE; COVERED STENT; TERUMO .035 GLIDE WIRE
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 89 YR